呕吐
恶心
奥氮平
医学
化疗引起恶心呕吐
止吐药
内科学
胃肠病学
养生
不利影响
临床终点
化疗
地塞米松
随机对照试验
NK1受体拮抗剂
化疗方案
麻醉
精神分裂症(面向对象编程)
受体
P物质
神经肽
精神科
作者
Shi Chen,Yiyan Pei,Hongwei Zhang,Ye Chen,Linge Deng,Xin Chen,Zhi‐Gong Wei,Dong Li,Zhihui Li,Ruidan Li,Zheran Liu,Xingchen Peng
摘要
Chemotherapy-induced nausea and vomiting (CINV) remains a prevalent treatment complication, often significantly impairing patients' quality of life and reducing adherence to chemotherapy regimens. The standard triplet antiemetic regimen, including either a neurokinin-1 (NK1) receptor antagonist (RA) or olanzapine, combined with a 5-hydroxytryptamine type 3 (5-HT3) RA and dexamethasone (DEX), faces challenges primarily due to DEX-related adverse effects and its potential to compromise the efficacy of antitumor agents. This study assessed whether omitting DEX (F-Group: olanzapine + 5-HT3 RA) is non-inferior to the standard D-Group (olanzapine + 5-HT3 RA + DEX). In this multi-center, double-blind, randomized phase III trial, 254 adults with malignant solid tumors (Eastern Cooperative Oncology Group [ECOG] 0-2) scheduled for highly emetogenic chemotherapy (HEC) were randomized 1:1 to the F-Group or D-Group. The primary endpoint was the complete response (CR; no emesis/rescue medication) rate over 0-120 h, with a non-inferiority margin of -15%. Secondary endpoints included CR and complete control (CC; no vomiting/nausea/rescue therapy) rates in acute (0-24 h) and delayed (25-120 h) phases, safety, and quality of life. Overall CR rates were 68.6% (D-Group) and 69.7% (F-Group; p = .9658), demonstrating non-inferiority. Acute phase CR rates were 88.4% versus 86.9% (p = .8643), and delayed phase CR rates were 69.4% versus 69.7% (p > .9999). CC rates were comparable across phases, with no new adverse reactions. The combination of a 5-HT3 RA and olanzapine is as non-inferior as the standard triplet regimen, providing an alternative option for patients receiving HEC. The trial was registered at ClinicalTrials.gov, number NCT05805800.
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